FDA 510(k) Application Details - K210820

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K210820
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Alliage S/A Industrias Medico Odontol≤gica Rod. Abrπo Assed, Km 53+450m Recreio Anhanguera 14097-500 BR Other 510(k) Applications for this Company
Contact	Daniel Camargo Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2021
Decision Date	08/10/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review